New stem cell rules ignite a battle on Beacon Hill

Incensed legislative leaders moved yesterday to reverse new restrictions on stem cell research, accusing health regulators in Governor Mitt Romney's administration of overstepping their authority and endangering the state's position as a leader in science.

Meanwhile, Lieutenant Governor Kerry Healey split with Romney, branding the regulations a mistake that would signal stem cell scientists that they are not welcome in Massachusetts.

The rules adopted Tuesday by the state Public Health Council generated widespread concern among scientists who expressed concern that the regulations could subject them to criminal penalties for certain activities used in human embryonic stem cell research. Some Democrats also said Romney, who appoints members of the health council, was taking a conservative position that could help him if he runs for president in 2008.

In an interview, Paul Cote , the state public health commissioner, acknowledged that the rules were developed in ``active dialogue" with Romney's office and that the Department of Public Health was told to close what Cote described as ``loopholes" that would allow embryos to be developed strictly for research. Romney supports research using embryos left over from in vitro fertilization but opposes the creation of cloned human embryos in order to harvest stem cells.

Cote, a Romney appointee, defended the regulations last night and called them ``a bright line to guide the researchers in the future as to what they can do and what they can't."

House Speaker Salvatore F. DiMasi described the new regulations on stem cells as outrageous. The Legislature in 2005 passed a law governing stem cell research and, in a statement, DiMasi said the regulations adopted Tuesday ``clearly fly in the face of both the law as passed and legislative intent."

DiMasi ordered the Joint Committee on Economic Development and Emerging Technologies to conduct a hearing on the regulations, and a committee representative said the hearing will take place by mid-September.

Representative Daniel E. Bosley , House chairman of the joint committee, said lawmakers would explore the steps they can take to block the new regulations. When legislators approved the stem cell law last year, their intention was to encourage research on human embryonic stem cells in Massachusetts.

Bosley said public health regulators had failed to notify legislators that a significant change in the stem cell regulation was being considered.

``You can't legislate by regulation," said Bosley, a North Adams Democrat. ``That's not only not kosher; it's against the law."

Eric Fehrnstrom , a Romney spokesman, said legislative committees were made aware of the proposed regulation.

Tim O'Brien , Healey's campaign manager, said in an e-mail that the lieutenant governor opposed the new rules because ``the field of stem cell research is still rapidly evolving, and it is a mistake to impose regulations that could have a chilling effect on those individuals at the forefront of this emerging field."

Embryonic stem cells have the capacity to become any cell in the body, and scientists say the research could lead to insights into disease and possibly treatments. One line of research by Harvard University scientists involves cloning embryos with the genes of a person with a particular disease they want to study.

But creating human embryonic stem cells using that technique, also called somatic cell nuclear transfer or SCNT, in humans is ``only an idea or an ideal at the moment," said Kevin Eggan, principal investigator at the Harvard Stem Cell Institute . And ``it may or may not ever become a reality."

Nevertheless, he said, ``It would be a shame to rule out any reasonable alternative" to SCNT.

If cloning the cells does not pan out, researchers may well try to create disease-specific batches of stem cells by seeking sperm and eggs from members of families that carry the disease. The resulting fertilized early embryos could be used to generate the disease-specific stem cells.

But the rules approved Tuesday would make that illegal. No researchers are currently using such methods, but the door would be closed to that approach.

``People are rightly focusing on [the question of] what are the other ways that one could go about making embryonic stem cell lines which could have the genes which cause a variety of genetic disorders," Eggan said.

``And certainly one way that one could imagine doing this is to ask people from affected families, who are in families that are studied for the disease.

Stephen Smith can be reached at stsmith@globe.com.